With the aim of regaining the Nasdaq listing requirement of a minimum bid price of $1, CTI BioPharma (NASDAQ:CTIC) will execute a 1:10 reverse split of its common stock effective on or about January 1, 2017. Post-split trading should commence on January 2.

A Phase 3 clinical trial, PERSIST-2, assessing CTI BioPharma's (CTIC+5.4%) pacritinib for the treatment of high-risk thrombocytopenic myelofibrosis achieved one of its two primary endpoints. The data are being presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.

PERSIST-2 randomized 311 subjects to receive either 200 mg of pacritinib twice daily, 400 mg of pacritinib once daily or best available therapy (BAT). The co-primary endpoints were the proportion of patients achieving at least a 35% reduction in spleen volume (SVR) from baseline to week 24 and the proportion of patients achieving at least a 50% reduction in Total Symptom Score (TSS) from baseline to week 24.

In a late-breaking oral presentation at the American Society of Hematology annual meeting Dec. 3-6, CTI BioPharma (NASDAQ:CTIC) will disclose data from its Phase 3 PERSIST-2 trial for comparing the investigational agent pacritinib, an oral multikinase inhibitor, with physician-specified best available therapy, including ruxolitinib, for treatment of patients with myelofibrosis whose baseline platelet counts are less than 100,000 per microliter.

Baxalta (NASDAQ:SHPG) and CTI BioPharma (NASDAQ:CTIC) have signed an agreement returning pacritinib to CTI. Under the terms of the contract, Baxalta will pay CTI a one-time cash payment of $10.3M as reimbursement for certain incurred or expected-to-be incurred expenses. CTI will repay the $10.3M upon the first regulatory approval or any pricing/reimbursement approval of any product containing pacritinib.

The original collaboration was with Baxter International, begun in 2013.

Baxalta, now Shire, cooled to developing pacritinib after mixed-results in a mid-stage myelofibrosis study and an FDA clinical hold due to certain side effects.

Pacritinib, an oral tyrosine kinase inhibitor, was under development for the potential treatment of certain blood-related cancers

Shire plc (NASDAQ:SHPG) has apparently lost its enthusiasm for myelofibrosis candidate pacritinib after mixed results in a mid-stage study. Also dampening the mood was a full clinical hold imposed by the FDA in February due to excessive deaths in the test group due to intracranial hemorrhage, cardiac failure and cardiac arrest.

Shire inherited the program by way of the Baxalta deal. Baxter International (NYSE:BAX) inked a collaboration with discoverer CTI BioPharma (NASDAQ:CTIC) in 2013 to develop the oral tyrosine kinase inhibitor for certain blood-related cancers. Baxter paid CTI $60M upfront and up to $112M in milestones for the privilege.

According to a regulatory filing by CTIC, the companies have entered into a non-binding term sheet regarding the termination of the collaboration agreement and the return of pacritinib to CTIC.

The results were generated from 221 patients who reached the primary analysis time point of Week 24 at the time the clinical hold was imposed by the FDA. Preliminary results showed a statistically significant response rate as measured by minimum spleen volume reduction (SVR) of 35% compared to BAT, including Jakavi (p<0.01). The other primary endpoint, at least a 50% reduction in Total Symptom Score (TSS) was not met (p=0.0791).

The FDA suspended the company's clinical development of pacritinib in February because of an abnormal number of deaths from intracranial hemorrhage, cardiac failure and cardiac arrest. It withdrew its New Drug Application (NDA) as a result.

Pacritinib, an oral tyrosine kinase inhibitor, is under development for the potential treatment of certain blood-related cancers.

After reviewing interim overall survival data in CTI BioPharma's (NASDAQ:CTIC) PERSIST-2 clinical trial assessing lead product candidate pacritinib, the FDA has informed the company that its Investigational New Drug (IND) application has been placed on full clinical hold. The basis for the decision was a similar detrimental effect on survival in PERSIST-2 that was observed in PERSIST-1.

The deaths in PERSIST-2 include intracranial hemorrhage, cardiac failure and cardiac arrest.

Full clinical hold means that no new patients can be recruited for the trials and all currently enrolled patients taking pacritinib must cease immediately. The company has withdrawn its New Drug Application (NDA), completed a month ago, until it has had the time to thoroughly review the data in PERSIST-2.

The agency's current recommendations include conducting dose exploration studies of pacritinib in patients with myelofibrosis, submitting final study reports and datasets for both PERSIST trials, providing certain notifications, revising certain statements in the investigator's brochure and informed consent documents and modifying the protocols.

The FDA has recommended to the company that it request a meeting prior to submitting a response to full clinical hold.

Micro cap CTI BioPharma (NASDAQ:CTIC) is down 27% premarket on average volume in response to its announcement that the FDA has placed clinical studies of lead product candidate pacritinib on partial clinical hold due to excess mortality and other adverse events in pacritinib-treated patients compared to control in the PERSIST-1 clinical trial. The abnormal mortality was most pronounced during the non-randomized crossover period following the initial 24 weeks of randomized treatment where patients in the control arm could switch to pacritinib.

Partial clinical hold means that no new patients can be recruited for any study or start pacritinib as initial or crossover treatment. Also patients not benefiting from pacritinib treatment after 30 weeks should cease taking pacritinib.

The FDA has recommended that the company modify its protocols for randomized studies to disallow crossover to pacritinib, provide certain notifications, revise certain statements in the investigator's brochure and informed consent documents and other actions.

CTI intends to submit the requested modifications as soon as possible. The FDA will notify it afterward whether it can continue clinical studies under its IND.

Pacritinib, an oral tyrosine kinase inhibitor, is under development for the potential treatment of certain blood-related cancers.